PURITAN-BENNETT COMPANION 550 LIQUID OXYGEN PORTABLE UNIT— 510(k) K933930

Substantially Equivalent

Puritan Bennett Corp.

FDA 510(k) clearance K933930 for PURITAN-BENNETT COMPANION 550 LIQUID OXYGEN PORTABLE UNIT, Substantially Equivalent on 1994-03-21. Applicant: Puritan Bennett Corp..

Clearance details

Applicant: Puritan Bennett Corp.
Product code: Code BYJ
Advisory panel: Anesthesiology
Date received: 1993-08-11
Decision date: 1994-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

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Adverse events under product code BYJ

product code BYJ

Death: 16
Total: 16

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.